This invention relates to a protector, primarily for use in medical applications. Its principal contemplated use is to surround and protect from contamination any connection site used by a patient in practicing a technique of kidney dialysis known as continuous ambulatory peritoneal dialysis.
Currently, the most widely used method of kidney dialysis for treatment of End Stage Renal Disease (ESRD) is "hemodialysis." Here, the patient's blood is cleansed by passing it through an artificial kidney in a kidney dialysis machine. By the process of diffusion across a semipermeable membrane in the artificial kidney, impurities and toxins are removed from the patient's blood to thereby perform a function of the patient's natural kidneys. Hemodialysis is required several times a week, each dialysis requiring several hours in a dialysis center or at home. During dialysis, the patient is "tied" to the machine by venous and arterial blood lines which convey his blood to and from the artificial kidney.
Although used less frequently than hemodialysis, a procedure known as "intermittent peritoneal dialysis" is an accepted method for treating ESRD. In this procedure, a dialysis solution is infused into the patient's peritoneal cavity by means of tubing and a catheter. The peritoneum, which defines the peritoneal cavity, contains many small blood vessels and capillary beds which act as a natural semipermeable membrane. This natural membrane may be contrasted with the artificial membrane used in hemodialysis. In both cases, however, impurities and toxins in the blood are removed by diffusion across a membrane--a cellulose membrane of an artificial kidney or a peritoneal membrane of a peritoneal cavity.
In intermittent peritoneal dialysis, dialysis solution remains in the patient's peritoneal cavity for a time sufficient for blood impurities to be removed by diffusion across the peritoneal membrane into the dialysis solution. The impurity containing dialysis solution then is drained from the peritoneal cavity by means of the catheter and tubing, and a fresh supply of dialysis solution is infused. Intermittent peritoneal dialysis utilizes pumps or other auxiliary equipment to which the patient is "tied" during dialysis; here also the patient must remain sedentary.
Continuous ambulatory peritoneal dialysis is another type of peritoneal dialysis which uses the peritoneum as a semipermeable membrane. This procedure has the important advantage, however, of enabling the patient to be ambulatory and conduct a normal routine during dialysis. The patient is not "tied" to a machine and he must be sedentary only for the time period required to drain and infuse dialysis solution from and into the peritoneal cavity. This infusion and draining is handled by tubing and a surgically implanted, indwelling catheter in the patient's abdominal wall and in communication with his peritoneal cavity.
The continuous ambulatory peritoneal dialysis procedure is intended to be a patient self-care technique once the catheter is surgically implanted. Thus, it is important that the apparatus involved, e.g., tubing solution container, and connections be simple and easy to use. The present invention is designed to be a simple and effective means of protecting any connection site between a patient's implanted catheter and a solution container of dialysis solution. The invention concerns a protector which surrounds and protects from contamination a connection site for use by a patient practicing continuous ambulatory peritoneal dialysis. This protector can be used, however, with a variety of medical devices which would fit within the protector.
Devices have been used in the past to secure and protect the connecting site of two ends of an external shunt typically implanted in the forearm of a patient being treated for kidney disease by hemodialysis. These devices were similar in design to the present invention, but did not include a material capable of holding a sterilizing agent in the device and in contact with the connection site.
With the advent of dialysis solution contained in plastic bags, and the development of continuous ambulatory peritoneal dialysis, it is desirable to have a simple contamination protector for use by patients to protect any connection site between a patient's tubing and a solution container. Typically, the connection site between the patient's indwelling catheter and the tubing through which dialysis solution flows is made by trained medical personnel in a clinical environment, and the tubing is not changed more frequently than once a month. However, at the distal end of the tubing, the patient connects and disconnects a dialysis solution container approximately four times per day. To prevent infection, it is extremely important that these connections be made in as aseptic a manner as possible and that the connection site remain free of debris and bacterial contamination. A simple effective contamination protector which would surround the connection site would be important, particularly from a patient self-care standpoint, when practicing continuous ambulatory peritoneal dialysis. It is, therefore an object of this invention to provide a contamination protector for connection sites in continuous ambulatory peritoneal dialysis, which is easy to open and close and is effective in preventing debris and bacterial contamination from entering the tubing at the connection site.
The protector of this invention comprises two halves which operate much like a "clamshell". The protector in the open position is placed around the connection site, the halves are swung to a closed position surrounding and in contact with the connection site, and secured in that position by a closure means. A gauze pad or other material soaked with an antibacterial agent such as povidone-iodine is first wrapped around the connection site by the patient and then secured in place by the protector. Alternatively, the protector can have integral with it a sponge or other like material impregnated with an antibacterial agent. In this embodiment, the antibacterial sponge remains with the protector and surrounds the connection site as the protector is closed.
Ease of operation of the protector is important since continuous ambulatory peritoneal dialysis is primarily a patient self-care technique, and because a large number of patients who practice continuous ambulatory peritoneal dialysis have limited physical capacity because of poor eyesight, weakness, arthritis and the like. This invention is also advantageous for use by children and geriatric patients.